PMDA device listing

テクスシールド

PMDA Medical device listing · 13B1X00226000037 · Class I

Key facts

PMDA document key 670397_13B1X00226000037_A_01
Brand names テクスシールド
General names (JMDN) 非天然ゴム製検査・検診用手袋
Product type Medical device
Device class (Japan) Class I
Approval, certification or notification number 13B1X00226000037
JMDN codes 70976000
Category code B0300
Marketing authorization holder 製造販売/ファーノ・ジャパン・インク
Package insert date Nov 25, 2022
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • Listed Listed on the PMDA site
  • No Refers to a technical manual

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA medical device and IVD listings (Japan)

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date:

Browse all PMDA medical device and IVD listings (Japan)